fesoterodine fumarate

FDA Drug Profile — Toviaz, fesoterodine fumarate

fesoterodine fumarate is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including Toviaz, fesoterodine fumarate. Available dosage form: tablet, film coated, extended release.

Drug Details

Generic Name
fesoterodine fumarate
Brand Names
Toviaz, fesoterodine fumarate
Application Number
NDA022030
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
6
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
FESOTERODINE FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release are indicated for the treatment of: • Overactive bladder(OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity Fesoterodine fumarate extended-release tablets are indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.